Product code LJZ— Microbiology
MYCOPLASMA IGG ELISA TEST SYSTEM
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Device class
- Class 1
- Regulation
- 21 CFR 866.3375
- Advisory panel
- Microbiology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code LJZ
FDA has cleared devices under product code LJZ between 1983 and 1999, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1999
- 1997
- 1994
- 1992
- 1991
- 1989
- 1983
Top applicants under product code LJZ
Recent clearances under product code LJZ
- K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
- K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM
- K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM
- K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM
- K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
- K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
- K934550 — IMMUNOCARD MYCOPLASMA
- K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
- K921556 — MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
- K904501 — MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
- K895276 — DIATECH IGM-MP TEST
- K882596 — MP TEST
- K823804 — MYCOPLASMELISA TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.